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PF-04895162

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 28, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment10
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01691274A Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Multiple Oral Doses Of PF-04895162PHASE1 COMPLETED 10 — — Oct 1, 2012Mar 1, 2013Mar 28, 20131 United States
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Study Endpoints
Primary Endpoints
Maximum observed plasma concentration (Cmax)
up to 12 h post dose for Days 1, 7 and 14
Time of maximum concentration (Tmax)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero extrapolated to inifinite time (AUCinf)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to the time of last quantifiable concentration (AUClast)
up to 12 h post dose for Days 1, 7 and 14
Area under the plasma concentration time profile from time zero to quantifiable concentration 24 h post dose (AUC24)
up to 12 h post dose for Days 1, 7 and 14
AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL)
up to 12 h post dose for Days 1, 7 and 14
t1/2 = Terminal Elimination half life
up to 12 h post dose for Days 1, 7 and 14
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
PF-04895162EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PF-04895162DRUGTablets, 300 mg, single, 1 day
PlaceboDRUGTablets, twice a day, 14 days
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Healthy male and/or female subjects of non-child bearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and puls...

Countries:United States
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